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Class 2 Device Recall ACCESS SARS CoV2 IgG (1st IS) Assay |
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| Date Initiated by Firm |
August 05, 2021 |
| Create Date |
September 22, 2021 |
| Recall Status1 |
Terminated 3 on June 01, 2023 |
| Recall Number |
Z-2508-2021 |
| Recall Event ID |
88612 |
| Product Classification |
Reagent, coronavirus serological - Product Code QKO
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| Product |
Access SARS CoV-2 IgG (1st IS) Assay:
Access Immunoassay Systems REAGENT PACK, REF C74339
Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340
Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341 |
| Code Information |
Part Number: C74339
UDI Code: (01)15099590746919(17)210930(11)210402(10)124466
Lot Number: 124466;
Part Number: C74340
UDI Codes:
(01)15099590746926(17)210930(11)210402(10)124467;
(01)15099590746926(17)211231(11)210703(10)124758;
Lot Numbers:
124467;
124758;
Part Number: C74341
UDI Codes:
(01)15099590746933(17)210930(11)210402(10)124468;
(01)15099590746933(17)211130(11)210602(10)124708;
Lot Numbers:
124468;
124708;
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Recalling Firm/
Manufacturer |
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
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| For Additional Information Contact |
Annette Hellie
714-831-7388
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Manufacturer Reason
for Recall |
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
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FDA Determined
Cause 2 |
No Marketing Application |
| Action |
On 08/06/2021, the firm sent an initial "URGENT MEDICAL DEVICE RECALL" Notification informing its customers that due insufficient evidence the firm was not issued an Emergency Use Authorization for its SARS-CoV-2 IgG (1st IS) assay and required to discontinue distribution and to recall all affected products. On 09/13/2021 the firm sent a revised "URGENT MEDICAL DEVICE RECALL UPDATE" to inform its customers about the potential risks/harms related to using the affected products, such as, the assay may generate discordant results such as false positive, false negative or misinterpreted results when compared to other World Health Organization (WHO) traceable assays.
Customers are instructed to:
1. Immediately discontinue using the Access SARS-CoV-2 IgG (1st IS) assay.
2. Discard all Access SARS-CoV-2 (1st IS) reagent packs, calibrators, and quality control.
3. A retrospective review of patient test results obtained with the Access SARS-CoV-2 IgG (1st IS) assay is not required. Any review is left to the discretion of the Laboratory Medical Director.
4. Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
5. If any of the affected products have been forwarded to another laboratory, provide them with the notification.
6. Complete and return the Customer Response Form within 10 days electronically via email or manually via mail
7. For credit for the affected products, complete the Customer Response Form
For questions, contact Customer Support Center via:
Website - http://www.beckmancoulter.com
Phone - 1-800-854-3633 in the United States |
| Quantity in Commerce |
303 kits (U.S.) and 964 kits (O.U.S.) |
| Distribution |
U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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